Aimmune Therapeutics Enrolls First Patient in RAMSES (ARC007), a
Phase 3 Clinical Trial of AR101 for the Treatment of Peanut Allergy

BRISBANE, Calif.--(EON: Enhanced Online News)--Aimmune Therapeutics, Inc. (Nasdaq:AIMT), today announced the enrollment
of its first patient in the Phase 3 RAMSES (ARC007) clinical trial of
AR101 for treatment of peanut allergy. AR101 is Aimmune’s
investigational biologic oral immunotherapy for desensitization of
patients with peanut allergy.

“Not requiring the diagnostic food challenge
requirement is more consistent with the way we practice, where the
diagnosis of peanut allergy is typically made based on a strong clinical
history and corroborating positive skin prick tests and/or elevated
blood levels of peanut antibodies.”

The Real-World AR101 Market-Supporting Experience
Study in Peanut-Allergic Children Age 4-17 Years, or RAMSES
(ARC007), trial is designed to gain experience with AR101 in a
real-world setting, without the use of a double-blind,
placebo-controlled food challenge (DBPCFC) to confirm peanut allergy. It
will assess the safety and tolerability of AR101 versus placebo. The
trial follows the same up-dosing and maintenance protocol as Aimmune’s
ongoing Phase 3 PALISADE trial, taking place in the United States,
Canada, and eight countries in Europe.

“The peanut-allergic patients in my practice have been highly motivated
to participate in Aimmune’s clinical trials. They’re looking for access
to a potential treatment, since peanut allergy patients are at risk for
life-threatening anaphylaxis and have to take extra caution with eating.
My patients have been happy to have the opportunity to participate in
these clinical trials and help with the effort which may lead to an
approved product to treat their problem,” said Stanley M. Fineman, M.D.,
Atlanta Asthma & Allergy. “Not requiring the diagnostic food challenge
requirement is more consistent with the way we practice, where the
diagnosis of peanut allergy is typically made based on a strong clinical
history and corroborating positive skin prick tests and/or elevated
blood levels of peanut antibodies.”

RAMSES (ARC007) is a randomized, double-blind, placebo-controlled trial
enrolling approximately 440 peanut-allergic patients ages 4–17 at
multiple sites in the United States and Canada. Patient selection is
based on stringent entry criteria, including a well-documented medical
history of IgE-mediated reactions to peanut (including anaphylaxis),
skin reactivity, and analyses of peanut-specific allergic antibodies.

The trial will monitor treatment-emergent adverse events during a
six-month up-dosing period, and then, after unblinding, follow patients
for at least six months on the maintenance dose of 300 mg of AR101 per
day. Aimmune anticipates that the absence of an entry food challenge may
improve the tolerability profile of AR101 in early stages of dosing by
removing exposure to high levels of peanut allergen that may otherwise
prime the immune system prior to treatment.

“We’re conducting our RAMSES trial not only to support regulatory
filings and real-world market understanding, but also to test whether
removing the entry food challenge can lead to improved tolerability of
AR101 during early up-dosing. Recent data from our collaborator Dr. Erik
Wambre and his colleagues at the Benaroya Research Institute on PALISADE
patient samples support the idea that the food challenge may activate
the immune system and thus increase the risk of additional allergic
reactions in the early up-dosing period that follows,” said Aimmune CMO,
Daniel Adelman, M.D. “Also, while some studies1,2 have shown
that food allergy patients and caregivers report improvements in quality
of life following food challenges, regardless of outcome, the process
can be emotionally tough. We’ve been hearing a lot of enthusiasm from
our PALISADE sites about starting RAMSES, and many of them have
waitlisted patients who are eager to participate in the trial.”

Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical
company developing treatments for life-threatening food allergies. The
company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™)
approach is intended to achieve meaningful levels of protection by
desensitizing patients with defined, precise amounts of key allergens.
Aimmune’s first investigational biologic product using CODIT™, AR101 for
the treatment of peanut allergy, has received the FDA’s Breakthrough
Therapy Designation for the desensitization of peanut-allergic patients
4-17 years of age and is currently being evaluated in Phase 3 clinical
trials. For more information, please see www.aimmune.com.

Statements contained in this press release regarding matters that are
not historical facts are “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding: Aimmune’s expectations for its RAMSES clinical
trial of AR101, including the expectation that the absence of a food
challenge in the trial may improve the tolerability of AR101; Aimmune’s
expectations regarding the potential benefits of AR101; and Aimmune’s
expectations regarding potential applications of the CODIT™ approach to
treating life-threatening food allergies. Risks and uncertainties that
contribute to the uncertain nature of the forward-looking statements
include: the expectation that Aimmune will need additional funds to
finance its operations; the company’s ability to initiate and/or
complete clinical trials; the unpredictability of the regulatory
process; the possibility that Aimmune’s clinical trials will not be
successful; Aimmune’s dependence on the success of AR101; the company’s
reliance on third parties for the manufacture of the company’s product
candidates; possible regulatory developments in the United States and
foreign countries; and the company’s ability to attract and retain
senior management personnel. These and other risks and uncertainties are
described more fully in Aimmune's most recent filings with the
Securities and Exchange Commission, including its Quarterly Report on
Form 10-Q for the quarter ended March 31, 2017. All forward-looking
statements contained in this press release speak only as of the date on
which they were made. Aimmune undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.

This press release concerns a product that is under clinical
investigation and that has not yet been approved for marketing by the
U.S. Food and Drug Administration (FDA) or the European Medicines Agency
(EMA). It is currently limited to investigational use, and no
representation is made as to its safety or effectiveness for the
purposes for which it is being investigated.